A digital consent procedure for rare disease - a prerequisite for Sweden´s contribution to 1+MG and other initiatives
| Reference number | |
| Coordinator | Region Skåne - Skånes Universitetssjukhus |
| Funding from Vinnova | SEK 6 035 240 |
| Project duration | November 2021 - September 2025 |
| Status | Completed |
Important results from the project
The main objective was to establish a platform enabling electronic informed consent for research studies, both for adults and for legal guardians to provide consent on behalf of their children. The model was tested within a national study on rare diseases. This objective has been met. A functional solution is now in place, and during the pilot phase, more than 4,400 consents have been registered in the database. In the next phase, all university hospitals in Sweden will be able to participate.
Expected long term effects
Citizens increasingly expect electronic services to be available for most purposes, and providing informed consent for research studies is no exception. The newly established platform has demonstrated key solutions, such as electronic login via BankID and linkage to the national population register, allowing legal guardians to consent on behalf of their children, all while maintaining essential security standards for sensitive personal data.
Approach and implementation
The platform was developed by one of the project partners, Uppsala University. The timeline was delayed due to the need for extensive code revisions, which also postponed patient inclusion for other partners. However, as noted above, a functional solution is now in place with several thousand registered research participants. The platform was also incorporated during the project period, an unexpected outcome that may be seen as advantageous, as the company can now support more research studies.